Amgen & Enbrel Marketing: Crossing Another Line?
7 CommentsBy Ed Silverman // February 6th, 2008 // 8:42 am
Two years ago, Amgen was worried about increased competition in the psoriasis market for its Enbrel medication. And the biotech has since been accused by former sales reps of encouraging various improper activities to boost prescriptions - reps were allegedly told to pull patient files from doctors’ office, orchestrate letter-writing campaigns to patients and insurers, and organize and attend patient outreach seminars.
In their complaints, the former sales reps say these efforts raised questions about off-label marketing and patient privacy. Meanwhile, one doctor banned Amgen from his clinic after being upset by a sales call from a district manager. The allegations are now being looked at by the New Jersey attorney general, the Florida attorney general and the US Senate Finance Committee.
Now, another alleged example of crossing a line has been brought to our attention. The accompanying e-mail is from the same district sales manager, and here she wrote to two Amgen regional medical liaisons about the Enbrel sales effort. For those unfamiliar with medical liaisons, these are the pharma employees who are supposed to help train sales reps about the science behind the drugs, champion investigator-initiated research and field queries from doctors, who may ask questions about topics that sales reps aren’t permitted to discuss, such as unapproved uses of meds.
The e-mail, though, suggests the district manager viewed the medical liaisons differently. As you can see, the district manager appears to be trying to pull them into the sales orbit - besides providing specific updates on new scrips written by two particular docs, she wants to “work together to blunt” the competition, in this case, the Humira med sold by Abbott Labs, and set up a “brief conference call.” Medical liaisons are viewed as a support function, but direct involvement in the sales effort is generally considered a no-no. This is the sort of overture that should be avoided.
One of the liaisons didn’t respond to a message and the other couldn’t be reached. An Amgen spokeswoman declined to comment on the e-mail specifically, citing the litigation. She did offer the same statement we have received previously when asking about Amgen’s marketing policies: “Amgen expects all staff to behave in a responsible and principled way. These expectations are detailed in our Code of Conduct, titled ‘Do the Right Thing,’ which includes: specific instructions with respect to proper promotion of Amgen products; guidelines for safeguarding confidential patient information; and channels for reporting violations of these policies. Our sales creed emphasizes that Amgen sales representatives follow compliance guidelines with absolute consistency.”
Matt
Sounds like standard drug company behavior to me.
Justice in Michigan
It’s beginning to sound like Warner-Lambert/Neurontin, but potentially worse, since Embrel AE’s can be considerably more serious. Let’s see if there is more to come.
Doc
This is standard operating procedure with pharma companies and their Medical Liasons. Any MD who has not requested that their RX data be blocked from field reps usage is a fool. Pharma companies continue to abuse this data with highly targeted sales efforts reminescent of a boiler room penny stock outfit.
ol cranky
Medical Affairs personnel, especially MSLs and field based docs, are routinely directly involved with sales reps that I think quite a few companies (and physicians) view people in these positions as the extension of the sales force that handles off label use.
SP
I can tell you from personal knowledge that at Schering-Plough the MSLs are regarded as “super” sales reps. They sometimes ride with the reps, visit the same docs and give promotional sales pitches. All without having the doctor ask for it. They’ve done it for the past 12-18 months and will continue to do it as long as they get away with it. if the MSLs don’t do it, and generate sales, then they’re fired!
Atlex
There are a few comments that deserve some further discussion.
* This may be very different from the WL/Neurontin case given that WL was accused of off-label promotion. As far as I know, Enbrel does have a couple of psoriasis indications in its label.
* Its not at all clear that any untoward behavior occured. For all we know, this DM may have been told that this was not an appropriate use of the MSL. More needs to come out before we even know if illegal or unethical actions took place.
* As to the comment regarding MSLs being responsible for sales. It is not inappropriate for an MSL to accompany a sales rep on physician calls where a more thorough medical discussions are warranted. Like all other times, they must abide by regulations that prevent them from off-label discussions unless there is an unsolicited request from a physician. Importantly, for most pharma companies, MSLs are not at all compensated for sales; this would automatically move them from a medical position to a sales position, thus disqualifying them from medical-to-medical discussions.
ol cranky
Atlex:
While it’s not appropriate for MSLs to do ride-alongs and solicit discussions of off-label use (or investigator sponsored studies), many of them do it whether they’re comfortable with the lack of compliance or not. While they are not compensated directly for off-label sales, they can be and are compensated indirectly (just as they can face not-so veiled criticism for not having the impact on those sales).
The degree of compliance is dependent on the corporate culture. The smaller the company is, the less likelihood personnel will have the guts to report pressures and concerns with compliance to the corp. compliance officer (heck, some companies don’t have one) because there really isn’t anonymity but there really is retaliation. Those who do report problems, often do so in resignations/exits interviews and I’m sure we’ve all heard the flurry of announcements from senior execs claiming those people are lying or violated regulations on their own and are only reporting it as they leave to cover their asses.